European Health Data Space Regulation
Navigation log
Table of Contents
Chapter I – General provisions
Chapter II – Primary use
Chapter III – Ehr systems and wellness applications
Chapter IV – Secondary use
Chapter V – Additional actions
Chapter VI – European governance and coordination
Chapter VII – Delegation of powers and committee procedure
Chapter VIII – Miscellaneous
Chapter IX – Deferred application, transitional and final provisions
Recitals (115)
Annexes
Article 21
Right to lodge a complaint with a digital health authority
1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint in relation to the provisions laid down in this Chapter, individually or, where relevant, collectively, with the competent digital health authority, provided that their rights or interests are negatively affected.
2. Where the complaint concerns the rights of natural persons pursuant to Articles 3 and 5 to 10 of this Regulation, the digital health authority shall transmit the complaint to the competent supervisory authorities under General Data Protection Regulation (GDPR). The digital health authority shall provide the necessary information at its disposal to the competent supervisory authority under General Data Protection Regulation (GDPR) in order to facilitate the assessment and investigation of the complaint.
3. The competent digital health authority with which the complaint has been lodged shall inform, in accordance with national law, the complainant of the progress made in dealing with the complaint, of the decision taken on the complaint, of any referral of the complaint to the competent supervisory authority under General Data Protection Regulation (GDPR) and, in cases of such a referral, that that supervisory authority is, from that moment on, to be the sole point of contact for the complainant in that matter.
4. Digital health authorities in the Member States concerned shall cooperate to handle and resolve complaints related to cross-border exchange of and access to personal electronic health data, including by exchanging all relevant information by electronic means, without undue delay.
5. Digital health authorities shall facilitate the submission of complaints and provide easily accessible tools for the submission of complaints.